Growth and Development in Children who underwent Cardiac Intervention before the age of 5
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Moderate Growth Failure -2SD to -3SD.
研究概览
简要总结
The study is a prospective observational cross sectional study to growth and neurodevelopmental outcome in children with congenital heart disease who underwent cardiac surgery or catherter based intervention before the age of 5. The study will be conducted in the Department of Paediatrics at Kasturba Medical College, Manipal. The primary outcome to measure to the neurodevelopmental outcome based on the developmental quotient of the child and growth will be assessed upon the Z-Score for weight for age and positive and negative correlation of Growth Failure and Neurodevelopmental delay will be compared with other factors present in the study population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who underwent corrective Cardiac Surgery or Catheter based Intervention for Congenital Heart Disease before the age of 5 At the Time of enrollment, at least 1 year has elapsed since the last corrective procedure was performed on the child.
排除标准
- •History of Birth Asphyxia or HIE.
- •History of stormy neonatal period with exclusive focus on those who suffered from Severe Intracranial Hemorrhage Meningitis Neonatal Seizures Sepsis TORCH infection and Neonatal Hyperbilirubinemia requiring Exchange Transfusion Extreme Prematurity at birth less than 28 weeks of gestation Syndromic etiology of Congenital Heart Disease.
结局指标
主要结局
Moderate Growth Failure -2SD to -3SD.
时间窗: At Baseline
Neurodevelopmental assessment based on the developmental quotient and categorized into
时间窗: At Baseline
Normal Neurodevelopmentally- DQ greater than 85
时间窗: At Baseline
Mild Neurodevelopmental Delay- DQ between 71 to 84
时间窗: At Baseline
Severe Neurodevelopmental Delay DQ less than 70
时间窗: At Baseline
Final Growth assessment will be based on the Z score for weight age-
时间窗: At Baseline
Normal Growth
时间窗: At Baseline
Mild Growth failure -1SD to -2SD
时间窗: At Baseline
Severe Growth Failure less than -3SD
时间窗: At Baseline
次要结局
- Positive or negative correlation of Growth Failure & Neurodevelopmental delay with other factors present in the study population.(At Baseline)
研究者
Dr Pushpa G Kini
KMC, Manipal